Dual versus triple therapy of Helicobacter pylori infection: results of a multicentre trial

Objective-To compare dual therapy (omeprazole and amoxicillin) with triple therapy (omeprazole, amoxicillin, and clarithromycin) in the treatment of H elicobacter pylori infection. The efficacy of 1 mg/kg/day omeprazole was ra ndomly compared with 2 mg/kg/day. Study design-252 patients (median age, 11.0 years; range, 3-18) presenting with chronic abdominal pain underwent endoscopy and a C-13-urea breath test . Gastric biopsy specimens were taken for histological examination and for the rapid urease test. Patients were treated for two weeks: group A (n = 63 ) received amoxicillin (50 mg/kg; maximum, 2 g/day), group B (n = 73) recei ved amoxicillin and clarithromycin (20 mg/kg; maximum, 1 gl day). Both grou ps were randomly treated with either I or 2 mg/kg omeprazole (maximum, 80 m g/day). Diagnostic procedures were repeated four weeks after the end of tre atment. Results-11 patients were excluded; 136 patients were H pylori positive (56% ), 105 of whom were re-examined after treatment whom were re-examined after treatment. Helicobacter pylori was eradicated in 52% of group A and 83% of group B. The dose of omeprazole had no influence on the eradication rate. Specificity and sensitivity of the rapid urease test were 94% and 93%, resp ectively. Specificity and sensitivity of the C-13-urea breath test were 93% and 95%, respectively. Conclusions-Dual therapy can no longer be recommended. Triple therapy is mo re effective than dual therapy in the eradication of H pylori infection. Th e lower dose of 1 mg/kg omeprazole was as effective as 2 mg/kg.